NCT02016040

Brief Summary

To evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®). Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one year. Evaluate the cost of hemi-ablation HIFU treatment. A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory) offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or T2b ). Precise mapping and characterisation of the disease will be established using multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2013

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

4.6 years

First QC Date

December 3, 2013

Last Update Submit

April 18, 2017

Conditions

Prostate Cancer

Keywords

Prostate cancerHIFU Hemi-ablationProstate biopsies

Outcome Measures

Primary Outcomes (1)

  • Rate of patients without cancer

    MRI,Biopsy,PSA

    Six months

Secondary Outcomes (3)

  • Immediate tolerance of hemi-ablation

    One year

  • Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life

    One year

  • Cost of hemi-ablation HIFU treatment

    One year

Study Arms (1)

HIFU hemi-ablation

ACTIVE COMPARATOR

Focal Therapy Using High Intensity Focused Ultrasound (Ablatherm)

Procedure: High Intensity Focused Ultrasound

Interventions

High Intensity Focused UltrasoundPROCEDURE
HIFU hemi-ablation

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age≥ 50 years
  • Clinical stage T1c (normal digital rectal examination) or T2a (one palpable nodule on digital rectal examination)
  • PSA ≤10 ng / mL
  • Presence of cancer on biopsies (12 sampling biopsies plus 2-4 targeted biopsies on one side and limited to one or two contiguous areas of prostate: basic and middle or middle and apex).
  • Gleason score ≤ 7 (3+4)
  • Flowmetry \> 12 mL / sec for a voided volume of 125 mL
  • PVR \<100 mL
  • Patient with normal anal and rectal anatomy.
  • Patient with a condition corresponding to a classification of ASA 1 or 2.
  • Patient signing ICF and agreed for following monitoring

You may not qualify if:

  • Patient with an ASA score 3.
  • Patient in clinical stage T1a, T1b, T2b, T2c or T3.
  • Patient with a tumor visible on MRI: Located at a distance less than 5 mm from the midline. Located less than 6 mm from the apex real
  • Metastatic lymph node or metastasis discovered by MRI and bone scan.
  • Patient previously treated for his prostate cancer by hormone therapy.
  • Patient with a distance between the rectal mucosa and prostate capsule over 8 mm thick
  • History of inflammatory bowel disease
  • Rectal fistula.
  • History of pelvic radiotherapy.
  • History of bladder cancer.
  • History of bladder neck sclerosis or urethral stenosis.
  • Patient with an implant located less than 1 cm from the treatment zone (stent, catheter).
  • Urogenital infection.
  • Latex allergy
  • Contraindication to MRI (pacemaker,metal prosthesis ...)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital,Urology Department

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Franck Bladou, MD

    Jewish General Hospital,Urology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Professor of Oncology and Urology, McGill University

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 19, 2013

Study Start

March 17, 2013

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

CA(1)